Deleted Tweets From , -D.C.

The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS.

Importantly, FDA evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.

To date, a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized.

Today we authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.

.@FDA_Drug_Info has published a From Our Perspective on the FDA’s Clinical Methodologies Group’s recent @HHSgov award, which will fund expansion of the CURE ID platform. https://t.co/BxBygnrPgn

As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 29 antigen tests.

The platform will allow automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases.

As part of our efforts to protect consumers, the agency issued a warning letter to one network operating two websites, premierdream(.)com and eirmed360(.)com, for marketing unapproved drugs for multiple diseases, including COVID-19.

Here’s an update on some of the actions we’ve taken in our ongoing response to the #COVID19 pandemic. https://t.co/B2MG7uEnPi https://t.co/LRwiBsELyg

While there are FDA-cleared/approved devices to help measure and monitor blood glucose, and dose and deliver insulin, there are no legally marketed medical devices in the U.S. intended to therapeutically improve glycemic control in patients with Type 2 diabetes.

Draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve glycemic control. https://t.co/tBjVkOFv7I https://t.co/yH32rn1jQK

RT @FDATobacco: Today, @US_FDA announced the agency’s commitment to evidence-based actions aimed at saving lives and preventing fut… https://t.co/iG216pNd8G

Washing your hands helps prevent #COVID19. But there are times you just can’t. Alcohol-based hand sanitizer is an alternative. If you use hand sanitizers, keep these safety tips in mind, especially around children. https://t.co/wxTflSWFha

FDA issued a warning letter to an operator of website pharmacygeoff(.)md for marketing unapproved drugs for multiple diseases, including #COVID19. https://t.co/P8C0iYs7Zr

Here are our latest actions in FDA’s ongoing response effort to the #COVID19 pandemic. https://t.co/0bavzkM7XT https://t.co/7JF3kpGDPc

Innovative medical products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist. #FDAVoices https://t.co/91NdHs8TO5

#NMHM21 #CancerControlMonth QT @FDAOncology: Non-Hispanic Blacks have higher rates of colorectal cancer incidence and death than other racial groups in the US.… https://t.co/Y13AHy5AIi)

RT @DrWoodcockFDA: Attention pet owners: Check your lot numbers if you have Meow Mix Original Choice Dry Cat Food. If you think your pet ha… QT @FDAanimalhealth: PET FOOD RECALL: The J.M. Smucker Company is recalling two lots of Meow Mix Original Dry Cat Food (sold in 30 lb. b… https://t.co/kr2Z8MlPVB)

You are protecting yourself and making a difference for your loved ones and your community by getting a #COVID19 vaccine when you are eligible. SHARE this info about the vaccine to others. #GetVaccinated https://t.co/k8YJRlfMdp

Over the past year, FDA’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate -- we are pursuing agency-wide preparedness efforts for resuming a more normal state of operations #FDAVoices https://t.co/iS9YPD4y1f

The Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine has been revised to include a warning about GBS and the Fact Sheet for Recipients and Caregivers has been revised to include information about GBS.

Importantly, FDA evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks.

To date, a total of five batches of Janssen drug substance that were manufactured at the Emergent facility have been authorized.

Today we authorized the use, under the emergency use authorization for the Janssen COVID-19 vaccine, of an additional batch of vaccine drug substance manufactured at the Emergent facility.

.@FDA_Drug_Info has published a From Our Perspective on the FDA’s Clinical Methodologies Group’s recent @HHSgov award, which will fund expansion of the CURE ID platform. https://t.co/BxBygnrPgn

As of today, 396 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 282 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 29 antigen tests.

The platform will allow automated anonymized data collection from electronic health records and clinical disease registries for COVID-19 and other difficult-to-treat infectious diseases.

As part of our efforts to protect consumers, the agency issued a warning letter to one network operating two websites, premierdream(.)com and eirmed360(.)com, for marketing unapproved drugs for multiple diseases, including COVID-19.

Here’s an update on some of the actions we’ve taken in our ongoing response to the #COVID19 pandemic. https://t.co/B2MG7uEnPi https://t.co/LRwiBsELyg

While there are FDA-cleared/approved devices to help measure and monitor blood glucose, and dose and deliver insulin, there are no legally marketed medical devices in the U.S. intended to therapeutically improve glycemic control in patients with Type 2 diabetes.

Draft guidance issued today provides the FDA’s initial thinking on feasibility and early feasibility clinical studies for certain medical devices intended to improve glycemic control. https://t.co/tBjVkOFv7I https://t.co/yH32rn1jQK

RT @FDATobacco: Today, @US_FDA announced the agency’s commitment to evidence-based actions aimed at saving lives and preventing fut… https://t.co/iG216pNd8G

Washing your hands helps prevent #COVID19. But there are times you just can’t. Alcohol-based hand sanitizer is an alternative. If you use hand sanitizers, keep these safety tips in mind, especially around children. https://t.co/wxTflSWFha

FDA issued a warning letter to an operator of website pharmacygeoff(.)md for marketing unapproved drugs for multiple diseases, including #COVID19. https://t.co/P8C0iYs7Zr

Here are our latest actions in FDA’s ongoing response effort to the #COVID19 pandemic. https://t.co/0bavzkM7XT https://t.co/7JF3kpGDPc

Innovative medical products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist. #FDAVoices https://t.co/91NdHs8TO5

#NMHM21 #CancerControlMonth QT @FDAOncology: Non-Hispanic Blacks have higher rates of colorectal cancer incidence and death than other racial groups in the US.… https://t.co/Y13AHy5AIi)

RT @DrWoodcockFDA: Attention pet owners: Check your lot numbers if you have Meow Mix Original Choice Dry Cat Food. If you think your pet ha… QT @FDAanimalhealth: PET FOOD RECALL: The J.M. Smucker Company is recalling two lots of Meow Mix Original Dry Cat Food (sold in 30 lb. b… https://t.co/kr2Z8MlPVB)

You are protecting yourself and making a difference for your loved ones and your community by getting a #COVID19 vaccine when you are eligible. SHARE this info about the vaccine to others. #GetVaccinated https://t.co/k8YJRlfMdp

Over the past year, FDA’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate -- we are pursuing agency-wide preparedness efforts for resuming a more normal state of operations #FDAVoices https://t.co/iS9YPD4y1f